Hevascol

Package leaflet: Information for the patient

Hevascol 480 mg I/mL injectable solution

ethiodized oil
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Hevascol is and what it is used for
2. What you need to know before being given Hevascol
3. How Hevascol is administered
4. Possible side effects
5. How to store Hevascol
6. Contents of the pack and other information

1. What Hevascol is and what it is used for

Hevascol belongs to the group of iodinated contrast agents.
This medicinal product is for diagnostic use only (for medical imaging procedures).
This medicine is used:

• For radiography: for imaging diagnostics of lymphatic vessels, lymph nodes, and fistulas, and for examination of the uterus and fallopian tubes during investigations for fertility problems.
• For interventional radiology: for transarterial chemoembolization (occlusion of blood vessels supplying the tumor by targeted chemotherapy) of liver tumors (hepatocellular carcinoma).

2. What you need to know before receiving Hevascol

Hevascol must not be administered

• if you are allergic to ethiodized oil.
• if you have an overactive thyroid (which may cause increased appetite, weight loss, or swelling).
• if you have recently had a serious injury or severe bleeding.
• if you require bronchography, a type of radiological examination in which contrast medium is instilled into the lower lung.
• if you currently have tuberculosis at the time of examination.
• if you have severe disease(s) affecting one or more organs in the body.
• if you have dilated bile ducts.
• if you are pregnant or think you might be pregnant and need to undergo hysterosalpingography (an examination of the uterus and Fallopian tubes).
• if you have pelvic inflammation (lower abdomen) affecting the uterus, Fallopian tubes, or ovaries and need to undergo hysterosalpingography (an examination of the uterus and Fallopian tubes).

Warnings and precautions
Talk to your doctor or pharmacist before using Hevascol.
As with all iodinated contrast agents, regardless of the route of administration or dose, adverse reactions may occur, which can be mild but also potentially life-threatening. These reactions may appear within one hour after administration or later, up to seven days afterward. They are often unpredictable, but the risk is higher if you have previously experienced an allergic reaction to an iodinated contrast agent (see section 4 “Possible side effects”). In such cases, inform your doctor.
Inform your doctor:

• if you have previously had a reaction to a contrast agent during an examination;
• if you have a history of allergic reaction to iodine;
• if you suffer from asthma;
• if you have a disease affecting the heart or blood vessels;
• if you have a disease affecting the lungs;
• if you have a disease affecting the liver;
• if you have a disease affecting the kidneys;
• if you have dilated veins in the esophagus;
• if you have a thyroid disease or a history of thyroid disease;
• if you are scheduled for a thyroid examination in the near future or treatment with radioactive iodine;
• if you have swelling in part or all of your hand or foot, including fingers, or in your legs (lymphedema).

In all these cases, your doctor will administer Hevascol only if the benefits of the examination outweigh the risks.
If you are given this medicine, your doctor will take the necessary precautions and closely monitor the administration of Hevascol.
In children or elderly patients, the doctor will pay particular attention when administering this medicine.

Other medicines and Hevascol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This particularly concerns the following medicines:

• a medicine used to treat diabetes (metformin);
• a medicine used to treat heart disease or high blood pressure (tablets that relax the heart and reduce blood pressure), diuretics (medicines used to remove water from the body);
• medicines known to be toxic to the kidneys (such as certain antibiotics, antivirals);
• interleukin-2 (a medicine used to treat cancer or to strengthen the immune system).

If you are taking a medicine for thyroid disease, inform your treating doctor before receiving Hevascol.

Hevascol and alcohol
If you regularly drink large amounts of alcohol, you must inform your doctor.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before receiving this medicine.

Pregnancy
This medicine must not be administered if you are pregnant or think you might be pregnant and need to undergo hysterosalpingography (an examination of the uterus and Fallopian tubes).

Breastfeeding
This medicine may be excreted in breast milk.
You must not breastfeed for at least 24 hours after administration of Hevascol.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
There are no specific known risks.
If you feel unwell after the examination, do not drive or operate machinery.

3. How Hevascol is administered

Dosage
Your doctor will determine the dose to be administered to you. The dose depends on various factors, including the type of examination or procedure you are undergoing.
Method of administration
This medicine will be administered by injection.
Before and after the examination or procedure, an infusion may be given to ensure you have sufficient fluids.
You may be given antibiotics to prevent possible infections that could occur during the examination or procedure.
During the examination, you will be monitored by a doctor. A venous cannula may be left in place so that the doctor can administer other medicines if needed in case of acute distress.
If an allergic reaction occurs, administration of Hevascol will be stopped.
The medical staff present are aware of the precautions required for the procedure and are also aware of potential complications that may arise.
If more Hevascol has been administered than you should have received
It is unlikely that you will receive an overdose of this medicine. This medicine is administered in a medical setting by experienced personnel. In the event of an overdose, appropriate treatment will be given.
For any further questions regarding the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
You may experience allergic reactions (including anaphylactic, anaphylactoid, and rapid-onset
allergic reactions). Allergic reactions may be recognized by the following symptoms:

• very rapid skin reactions (often within one hour), with skin blisters, redness (erythema), and itching (localized or widespread), sudden swelling of the face and neck (angioneurotic edema)
• respiratory effects: cough, nasal inflammation (runny nose), sensation of throat tightness, difficulty breathing, swollen throat (laryngeal edema), breathing difficulty with cough (bronchospasm), respiratory arrest
• effects on heart and blood vessels: low blood pressure (hypotension), dizziness, malaise (weakness), heart rhythm problems, cardiac arrest
  If you experience any of these side effects during or after administration of Hevascol, inform your doctor immediately.

Other possible side effects
The side effects observed following use of this medicine are listed below.
Their frequency is unknown (cannot be estimated from the available data).

• nausea (feeling unwell)
• vomiting (nausea)
• diarrhea
• pancreatitis (inflammation of the pancreas)
• fever
• injection site pain
• underactive thyroid (which may cause fatigue or weight gain)
• overactive thyroid (which may cause increased appetite, weight loss, or swelling)
• blockage of certain blood vessels in the lungs (pulmonary embolism), which may lead to excessive fluid accumulation in the lungs (pulmonary edema) and surrounding area (pleural effusion), critical respiratory failure (acute respiratory distress syndrome), pneumonia
• embolism (blockage of blood vessels) in the brain. This may occur without clinical signs.
• worsening of lymphedema (swelling caused by impaired lymphatic system function)
• shortness of breath
• cough
• liver damage due to liver failure, abnormal accumulation of fluid in the abdominal cavity (ascites), insufficient blood perfusion that may cause liver damage (hepatic infarction), altered level of consciousness, which may be related to other neurological symptoms caused by liver failure (hepatic encephalopathy)
• pus formation (abscess) in the liver
• inflammation of the gallbladder or fallopian tubes or peritonitis
• bile collection in the abdominal cavity (bile leak or biloma)
• skin necrosis (tissue death)
• post-embolization syndrome (fever, abdominal pain, nausea, and vomiting) that may occur after administration of this medicine during transarterial chemoembolization (occlusion of blood vessels supplying the tumor using targeted chemotherapy)
• small amounts of Hevascol may leak into the bloodstream and reach other parts of the body, such as blood vessels or arteries.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hevascol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial after EXP (Exp).
The expiry date refers to the last day of that month.
Store the vial in the outer packaging to protect it from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Hevascol contains
The active substance is ethiodized oil. 1 mL of injection solution contains 480 mg of iodine.
This product does not contain excipients.

Description of the appearance of Hevascol and contents of the pack
Hevascol injection solution is a clear oily liquid ranging in colour from pale yellow to amber.
It is available in 10 mL vials.

Marketing Authorisation Holder
Guerbet
BP 57400
95943 Roissy CdG cedex
France

Manufacturer
Guerbet
16-24 rue Jean Chaptal,
93600 Aulnay-sous-Bois,
France

This medicinal product is authorised in the following European Economic Area Member States under the following names:
Croatia: Lodiolip
Cyprus: Hevascol
Czech Republic: Hevascol
Finland: Hevascol
Greece: Hevascol
Norway: Hevascol
Poland: HEVASCOL
Romania: Hevascol
Slovak Republic: Lodiolip
Slovenia: Hevascol
Spain: Hevascol
Sweden: Hevascol

The following information is intended for healthcare professionals only:

Posology and method of administration

Posology

In diagnostic radiology:

Lymphangiography
Injection of Hevascol into a peripheral lymphatic vessel enables visualisation of the lymphatic system up to the thoracic duct. Prior to injection of Hevascol, an appropriate sterile dye solution may be administered to facilitate localisation of lymphatic collectors. Common administration sites include the dorsum of the foot or hand, in the first, third or fourth interdigital space. After dissection under local anaesthesia, the stained vessels are cannulated with a specific cannula; Hevascol should be injected with the patient in the supine position. A slow infusion pump is required for administration. The infusion rate must not exceed 0.1 mL/minute and should be adjusted according to the flow capacity of the lymphatic system. If the patient experiences pain at the injection site, the infusion rate should be reduced. The flow of contrast medium must be monitored by radiography to allow early detection of extravasation or incorrect cannulation. Infusion should be stopped when the contrast level reaches the fifth lumbar vertebra. Radiographs obtained after completion of the infusion (filling phase: lymphangiography) and the following day (deposition phase: lymphadenography) provide information on morphological changes in the lymphatic vessels and lymph nodes examined.

Recommended dosage
Generally, a maximum of 4 to 7 mL of Hevascol per limb is administered in adults to visualise inguinal, iliac and para-aortic lymph nodes. When lymph nodes are clearly enlarged, up to 10 mL per limb may be injected. Pulmonary oil microembolism may be observed on chest radiography at total doses exceeding 14 mL. The maximum total dose of contrast medium must not exceed 20 mL. In cases where there is no deposition function in the iliac and para-aortic lymph nodes (e.g. after radiotherapy or lymphadenectomy), the dose should be halved.

For imaging of axillary lymph nodes using the dorsum of the hand, 3 to 6 mL of Hevascol are sufficient.

Elderly patients
In elderly patients with cardiorespiratory insufficiency, the dose should be adjusted or the examination avoided altogether, as part of the product will temporarily embolise pulmonary capillaries. Administer the drug with caution in patients over 65 years of age who have cardiovascular, respiratory or neurological disorders.

Paediatric population
The dose should be proportionally reduced in children and underweight patients. In infants aged 1 and 2 years, a dose of 1 mL per limb is sufficient.

Fistulography
The amount of contrast medium to be administered should be determined prior to the examination, based on the estimated size of the fistula.

For a single examination, Hevascol is generally administered as a single dose.

Hysterosalpingography
Under fluoroscopic guidance, inject 2 mL of Hevascol slowly at a time into the uterine cavity until tubal patency is determined.

The total volume to be injected depends on the capacity of the uterine cavity and generally does not exceed 15 mL.

The dose of Hevascol for hysterosalpingography should be kept as low as possible to minimise the potential risk of thyroid dysfunction.

During hysterosalpingography, the contrast agent is slowly injected into the cervical canal using an appropriate catheter or cannula.

If the patient experiences significant discomfort, discontinue the injection.

The examination should preferably be performed during the follicular phase of the menstrual cycle.

In interventional radiology:

Transarterial chemoembolisation of hepatocellular carcinoma
Administration is performed via selective intra-arterial catheterisation of the hepatic artery. The procedure must be carried out in a typical interventional radiology setting with appropriate equipment. The dose of Hevascol depends on the extent of the lesion, but generally must not exceed a total dose of 15 mL in adult patients.

Hevascol may be mixed with antineoplastic agents such as cisplatin, doxorubicin, epirubicin and mitomycin.

Carefully follow the instructions and precautions for use of antineoplastic drugs.

Instructions for preparing the Hevascol and antineoplastic drug mixture:

• Prepare two sufficiently large syringes to contain the total volume of the mixture. The first syringe contains the antineoplastic drug, the second contains Hevascol.
• Connect the two syringes to a three-way stopcock.
• Transfer the contents between the syringes 15–20 times to obtain a homogeneous mixture. It is recommended to start by depressing the plunger of the syringe containing the antineoplastic drug first.
• The mixture should be prepared immediately before use and must be used immediately after preparation (within 3 hours). If necessary during the interventional radiology procedure, repeat the homogenisation of the mixture as described above.
• Once an adequate mixture has been obtained, use a 1–3 mL syringe to inject the mixture into the microcatheter. The procedure may be repeated every 6–8 weeks depending on tumour response and patient condition.

Paediatric population
The efficacy and safety of Hevascol in transarterial chemoembolisation of hepatocellular carcinoma have not been established in the paediatric population.

Elderly patients
Administer the product with particular caution in patients over 65 years of age who have underlying cardiovascular, respiratory or nervous system disorders.
A reduction in the administered dose may prevent non-targeted pulmonary emboli that may occur during hepatic chemoembolisation.

Method of administration
Administer Hevascol using a suitable glass syringe or other device for which compatibility studies with Hevascol have been conducted. Follow the current instructions for use applicable to these devices.

Incompatibilities
Hevascol has been shown to dissolve polystyrene; therefore, disposable polystyrene syringes must not be used for administration of this preparation. Administer Hevascol using a suitable glass syringe or other device for which compatibility with Hevascol has been confirmed by study. Follow the current instructions for use applicable to these devices.